Packaging and storage— Preserve in well-filled, tight containers, and avoid exposure to excessive heat.

Labeling— The label states the Latin binomial name and, following the official name, the part of the plant source from which the article was derived. The label also states that if solid material has separated, carefully warm oil until it is completely liquefied, and mix before using.

Solubility in 90 percent alcohol— One volume dissolves in 3 volumes of 90 percent alcohol.

Specific gravity 841: between 0.978 and 0.988.

Congealing temperature 651: not lower than 15.

Angular rotation 781A: between –2 and +1.

Refractive index 831: between 1.553 and 1.560 at 20.

Heavy metals, Method II 231: 0.004%.

Limit of phenols— A solution of recently distilled Anise Oil in 90 percent alcohol (1 in 3) is neutral to moistened litmus paper, and the solution develops no blue or brownish color upon the addition of 1 drop of ferric chloride TS to 5 mL of the solution.

Residual solvents 467: meets the requirements.

Expert Committee : (CRX05) Compounding Pharmacy05

USP29–NF24 Page 3275

Phone Number : 1-301-816-8243